Airway Data Collection With the Entarik Feeding Tube System

NCT06760572 | Recruiting FDA Device

• 2 other identifiers: CRD-04-1877-01R44AG076248
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the airway detection performance of the Entarik Feeding Tube System, and to collect data when the Entarik Feeding Tube is in the Airway for device development.

Conditions

Healthy

Keywords

Feeding Tube; feeding tube placement safety; feeding tube placement

Outcome Measures

Primary Outcomes (2)

• Percentage of accurate airway verifications by the Entarik feeding tube system

  Percentage of accurate verifications of airway placement of the tip of the Entarik feeding tube at the Safety Check Depth.

  During the airway placement procedure

• Incidence of Adverse Events

  Incidence of adverse events: (a) related to placement and (b) throughout the duration of the presence of the feeding tube within the subject.

  During the airway placement procedure

Study Arms (1)

Healthy Adults

EXPERIMENTAL

Airway insertion

Device: Airway insertion

Interventions

Airway insertion DEVICE

Tube will be inserted into the trachea to make airway data measurements.

Healthy Adults

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years old.
• Able to provide informed consent.
• Adults scheduled to undergo a bronchoscopy procedure who will be intubated as part of the standard of care.

You may not qualify if:

• Known major upper airway malformation.
• Presence of clinically significant respiratory infection.
• Known bleeding disorder.
• Currently pregnant.
• Current basilar skull fracture.
• Known sensitivities or allergies to the feeding tube components.
• Deemed unsuitable for enrollment in study by the investigator based on subject's history (e.g., active anticoagulation therapy) or physical examination.

Sponsors & Collaborators

• Theranova, L.L.C.: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

RECRUITING

Study Officials

• Daniel Burnett, MD

  Theranova, LLC

  STUDY DIRECTOR

Central Study Contacts

Aaron Miller

CONTACT

415-926-8616; clinicalstudy@theranova.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2024
• First Posted: January 7, 2025
• Study Start: February 13, 2025
• Primary Completion: December 12, 2025
• Study Completion: December 12, 2025
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)